Seoul Cosmetics Co., Ltd.
🚨 Critical Risk
FEI: 3007253462 • Namdong District, Incheon • SOUTH KOREA
FEI Number
3007253462
Location
Namdong District, Incheon
Country
SOUTH KOREAAddress
12 Namdongdongro63beon-Gil, , Namdong District, Incheon, South Korea
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REFUSE EI
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/18/2025 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/8/2025 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3845DRG REF EI | Division of Southeast Imports (DSEI) |
| 8/21/2025 | 53EY01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | Division of Southeast Imports (DSEI) | |
| 8/21/2025 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/31/2025 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/16/2025 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 5/15/2025 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of West Coast Imports (DWCI) | |
| 5/9/2025 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of West Coast Imports (DWCI) | |
| 5/9/2025 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | Division of West Coast Imports (DWCI) | |
| 4/17/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 3/26/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/26/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/26/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/4/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/4/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/4/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/4/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/4/2025 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/22/2025 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 1/22/2025 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 12/17/2024 | 53YA99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 3845DRG REF EI | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/13/2024 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/13/2024 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 7/24/2024 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 7/24/2024 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 1/16/2024 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 12/27/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/19/2023 | 53LA06MOISTURIZING (SKIN CARE PREPARATIONS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 10/19/2023 | 53LA06MOISTURIZING (SKIN CARE PREPARATIONS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 10/19/2023 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 10/19/2023 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 6/7/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 3/24/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 6/27/2022 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 6/3/2022 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 1/21/2022 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 5/21/2021 | 53LY06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 5/7/2021 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 5/7/2021 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 1/25/2021 | 65LBY99PROTECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/25/2021 | 65LBY99PROTECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/25/2021 | 65LBY99PROTECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 11/12/2020 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/2/2020 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of Northern Border Imports (DNBI) |
| 9/24/2020 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/30/2019 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53FC99OTHER HAIR COLORING PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 9/30/2019 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 7/11/2019 | 53FC99OTHER HAIR COLORING PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 7/11/2019 | 53FC99OTHER HAIR COLORING PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 7/11/2019 | 53ED02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 7/11/2019 | 53FC99OTHER HAIR COLORING PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 7/11/2019 | 53FC99OTHER HAIR COLORING PREPARATIONS, N.E.C. | 3600REFUSE EI | Division of West Coast Imports (DWCI) |
| 1/15/2019 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Southwest Imports (DSWI) |
| 5/23/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Seoul Cosmetics Co., Ltd.'s FDA import refusal history?
Seoul Cosmetics Co., Ltd. (FEI: 3007253462) has 100 FDA import refusal record(s) in our database, spanning from 5/23/2017 to 11/18/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Seoul Cosmetics Co., Ltd.'s FEI number is 3007253462.
What types of violations has Seoul Cosmetics Co., Ltd. received?
Seoul Cosmetics Co., Ltd. has been cited for 10 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Seoul Cosmetics Co., Ltd. come from?
All FDA import refusal data for Seoul Cosmetics Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.